Quality & Regulatory

Aptar CSP Technologies is passionate about quality, and about designing products that exceed customer expectations. Our process is both intricate and thorough: Initial design risk assessments are conducted using Design of Experiments (DOEs) to establish optimum production processes and ensure robust product quality.

Aptar CSP Technologies aims to consistently deliver up to a Six Sigma quality level for critical defects. We are committed to continuous improvement and have a proven track record of success. Our facilities have been ISO-9001 certified since 1994.

  • Six Sigma
  • Global Regulatory Support
  • Product Stewardship
  • ISO-9001

Aptar CSP Technologies provides regulatory compliance and support to meet the needs of our customers in the pharmaceutical, medical device, diagnostics, and food products industries with strict adherence to regulatory guidelines. We provide comprehensive regulatory support, to ensure our solutions comply with regulatory requirements.

Aptar CSP Technologies manufacturing plants meet requirements set forth by the U.S. Food and Drug Administration (FDA) and are compliant with the FDA’s Current Good Manufacturing Practice (cGMP) regulations. Our proprietary three-phase Activ-PolymerTM formulations are included in a Drug Master File (DMF #14789). Aptar CSP’s plants only use materials for manufacturing products that are Generally Recognized as Safe (GRAS). Production is completed under Good Manufacturing Practices (GMPs).